UPDATE: Okay, I just finished listening to the podcast. It was certainly informative, but left me with a few critical questions. Dr. Jean Ah Kang, the person Senak interviewed, was helpful because she clarified a few points:
• It’s About Content, Not Context: She said that enforcement is about the message (or content), not the medium. She mentioned the Shire YouTube video enforcement action and noted that it was all about fair balance and efficacy claims and not the fact it was posted to YouTube.
• We Focus On Well-Established Regulatory Principles: Regardless of the communications channel or technology, DDMAC continues to focus on the core regulatory principles of fair balance and accuracy that govern all pharma marketing efforts
• It’s All About Control: DDMAC looks at the context of the marketing effort, i.e., whether the company (or its agents) are controlling the production and distribution of the content. So, if a third party not affiliated with a company uses or repurposes content, DDMAC is not likely to blame a company for something outside of its control.
(I should note that we focused on and communicated these concepts in the white paper we developed back in 2007 regarding regulatory issues related to pharma social media marketing. It’s nice to know our guidance was on the right track.)
However, Kang did not really address the speed issue. Specifically, she invited companies to submit materials to FDA before they go out into the marketplace. However, a branded blog, Twitter or social network campaign can change at any time and for any reason. It is not feasible for companies to pre-submit this type of content to the FDA before it is distributed. This question needs to be addressed by DDMAC. There is also the issue of adverse event reporting, which was also not touched upon.
Otherwise, this was an interesting interview, but it left a few critical questions unanswered.
Original Post
I was planning on writing about the ongoing troubles of the newspaper industry
and what this may mean for health public relations, but my plans were pre-empted when I saw a tweet from @mindofandre (Andre Blackman). He turned me on to a podcast Mark Senak of Eye On FDA conducted with the FDA regarding pharmaceutical companies and social media. Not just anyone at FDA, but someone from DDMAC, the agency division responsible for regulating biopharmaceutical and medical device marketing activities.
For those of us thinking about how to conduct regulatory compliant marketing using social technologies, this podcast is a must-listen. Now, I must admit that I have not listened to it yet, but I thought it was so important that I decided to blog about it first and in order to spread the word about this very important resource.
To listen to the podcast, click here.
Fard,
I thought she had absolutely nothing new to say nor anything that any pharma person does not know already. And her discussion of how to submit materials for "pre-approval" was not only untenable for social network marketing, it was also laughable -- go to the FDA web site and find this and that! Annotate, annotate, annotate! C'mon! This is FDA 101 stuff that any pharma person knows.
You make a good point: While FDA regulations may be media-agnostic, the submission process must be optimized for specific media.
See my post here: http://tinyurl.com/clxx63
John
Posted by: John Mack | March 18, 2009 5:05 AM | Permalink to Comment